search
Back to results

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

Primary Purpose

Neuromuscular Scoliosis, Adolescent Idiopathic Scoliosis

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Scoliosis focused on measuring Steroid, Dexamethasone, Scoliosis

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must meet all of the inclusion criteria to participate in this study: • Patients aged 9-18 years who are scheduled to undergo posterior spinal fusion to treat AIS or NMS Exclusion Criteria: Patients will be excluded if any of the following criteria are met at baseline: Prior instrumentation or spine surgery Conditions associated with increased wound healing issues such as spina bifida Non AIS or NMS patients Not undergoing PSF Outside the ages of 9-18 Allergies to the steroids and/or their ingredients Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Sites / Locations

  • Children's Hospital Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Steroid (NS)

With Steroid (WS)

Arm Description

No Dexamethasone (NS)

With Dexamethasone (WS)

Outcomes

Primary Outcome Measures

Length of Stay
Day/hours to discharge from hospital following completion of surgery.
Post Operative Opioid Use
Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg)

Secondary Outcome Measures

Post Operative Ambulation (for ambulatory patients)
Will obtain number of feet ambulated with physical therapy (PT) staff on each post operative day. Will record number of days postoperatively until PT clearance for discharge.
Return of Bowel Function
Will record time to return of bowel sounds as noted by nursing or house staff. Will record time to first bowel movement.
Rate of wound complications requiring intervention
3.1) Additional clinic visits for drainage or wound concerns will be recorded. 3.2) Use of antibiotic for superficial wound issues will be recorded. 3.3) Any additional operative intervention or hospitalization for concern/management of an infection.
Scar Appearance
Clinical photos will be obtained and graded with Stony Brook Scar Evaluation Scale. The Stony Brook Scar evaluation scale ranges from a minimum value of 0 (worst) to a maximum value of 5 (best).
Patient-Reported Outcomes Measurement Information System (PROMIS)
The Patient-Reported Outcomes Measurement Information System is a validated quality of life and outcome questionnaire used for various studies. This will also be completed by the parent, if the patient is unable to do so. PROMIS domains that will be utilized include: pain interference A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used. A higher score is indicative of more problems with pain hindering activities than a lower score. physical activity A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used. A higher score is indicative of engagement with more physical activities than a lower score. mobility A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used. A higher score is indicative of engagement with more mobility than a lower score.
Post-Operative Complications
Any additional emergency room visits/readmission or revision surgery
Body Mass Index
Weight, measured in kilograms, and height, measured in meters, will be combined to report body mass index in kg/m^2

Full Information

First Posted
August 8, 2023
Last Updated
September 1, 2023
Sponsor
Children's Hospital Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT06023043
Brief Title
Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients
Official Title
A Randomized Trial of Postoperative Steroid Use Following Posterior Spinal Fusion in 100-subject Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis (NMS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion. The main question it aims to answer are: What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)? Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation? Participants will: Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years Have clinical photos of their incision at 3 months, 1 year, and 2 years Their photos will be assessed using the stony book scar evaluation scale For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand. Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.
Detailed Description
Children remain a vulnerable population historically known to be undertreated and underrecognized for their pain, only perpetuating the complexity of managing pain control in this cohort. Children's Hospital of Los Angeles conducted a study observing patient and family's perioperative perception regarding their posterior spinal fusion and found that pain control is a primary concern, however, surgeons did not share the sentiment. Opioids were primarily the medication of choice with dentists and surgeons accounting for approximately two-thirds of opioid prescriptions. However, with the rise of the national opioid crisis and its adverse effects not limited to addiction, providers are gravitating towards alternative multidisciplinary use of medication to manage pain. Though steroids were formerly used for surgical patients, concerns regarding increased surgical site infection and wound healing complications were of major concern. However, to the investigators knowledge, these issues have only been documented with chronic steroid use. The impact of immediate use of steroids postoperatively for accelerated discharge has gained momentum in the literature with its demonstration in facilitating earlier mobility, decreased pain scores, and decreased narcotic usage. A retrospective study suggested that post-operative dexamethasone administration can have the positive effect of reducing opioid use in pediatric PSF patients without increasing wound complications. The proposed study aims to rigorously observe the effects of post operative steroid use in its facilitation in early mobilization in adolescent PSF patients, while also understanding the incidence of wound complications and long-term scar formation. Should the randomized controlled trial align with the literature, the implementation of post-operative steroids could potentially alter standard of care for adolescent PSF patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Scoliosis, Adolescent Idiopathic Scoliosis
Keywords
Steroid, Dexamethasone, Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Steroid (NS)
Arm Type
No Intervention
Arm Description
No Dexamethasone (NS)
Arm Title
With Steroid (WS)
Arm Type
Experimental
Arm Description
With Dexamethasone (WS)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Three (3) post operative intravenous dexamethasone injections at 8-hour intervals post-operatively. Dosing will be determined as 0.15 mg/kg per dose (WS)
Primary Outcome Measure Information:
Title
Length of Stay
Description
Day/hours to discharge from hospital following completion of surgery.
Time Frame
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Title
Post Operative Opioid Use
Description
Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg)
Time Frame
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Secondary Outcome Measure Information:
Title
Post Operative Ambulation (for ambulatory patients)
Description
Will obtain number of feet ambulated with physical therapy (PT) staff on each post operative day. Will record number of days postoperatively until PT clearance for discharge.
Time Frame
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Title
Return of Bowel Function
Description
Will record time to return of bowel sounds as noted by nursing or house staff. Will record time to first bowel movement.
Time Frame
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Title
Rate of wound complications requiring intervention
Description
3.1) Additional clinic visits for drainage or wound concerns will be recorded. 3.2) Use of antibiotic for superficial wound issues will be recorded. 3.3) Any additional operative intervention or hospitalization for concern/management of an infection.
Time Frame
Less than 90 days from hospitalization
Title
Scar Appearance
Description
Clinical photos will be obtained and graded with Stony Brook Scar Evaluation Scale. The Stony Brook Scar evaluation scale ranges from a minimum value of 0 (worst) to a maximum value of 5 (best).
Time Frame
Immediately from enrollment through study completion, at an average of 2 years
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
The Patient-Reported Outcomes Measurement Information System is a validated quality of life and outcome questionnaire used for various studies. This will also be completed by the parent, if the patient is unable to do so. PROMIS domains that will be utilized include: pain interference A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used. A higher score is indicative of more problems with pain hindering activities than a lower score. physical activity A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used. A higher score is indicative of engagement with more physical activities than a lower score. mobility A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used. A higher score is indicative of engagement with more mobility than a lower score.
Time Frame
Immediately from enrollment through study completion, at an average of 2 years
Title
Post-Operative Complications
Description
Any additional emergency room visits/readmission or revision surgery
Time Frame
Within 2 years from date of surgery.
Title
Body Mass Index
Description
Weight, measured in kilograms, and height, measured in meters, will be combined to report body mass index in kg/m^2
Time Frame
Immediately from enrollment through study completion, at an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the inclusion criteria to participate in this study: • Patients aged 9-18 years who are scheduled to undergo posterior spinal fusion to treat AIS or NMS Exclusion Criteria: Patients will be excluded if any of the following criteria are met at baseline: Prior instrumentation or spine surgery Conditions associated with increased wound healing issues such as spina bifida Non AIS or NMS patients Not undergoing PSF Outside the ages of 9-18 Allergies to the steroids and/or their ingredients Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay M Andras, MD
Phone
323-361-2142
Email
landras@chla.usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Phan, BA
Email
tphan@chla.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Andras, MD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Phan
Phone
310-848-8377
Email
tphan@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Lindsay Andras, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27927519
Citation
Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16.
Results Reference
background
PubMed Identifier
33093753
Citation
Keohane D, Sheridan G, Harty J. Perioperative steroid administration improves knee function and reduces opioid consumption in bilateral total knee arthroplasty. J Orthop. 2020 Oct 7;22:449-453. doi: 10.1016/j.jor.2020.10.004. eCollection 2020 Nov-Dec.
Results Reference
background
PubMed Identifier
33086348
Citation
Fletcher ND, Ruska T, Austin TM, Guisse NF, Murphy JS, Bruce RW Jr. Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. J Bone Joint Surg Am. 2020 Oct 21;102(20):1807-1813. doi: 10.2106/JBJS.20.00259.
Results Reference
background
PubMed Identifier
24809068
Citation
Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7.
Results Reference
background
PubMed Identifier
25554755
Citation
Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain Outcomes in a US Children's Hospital: A Prospective Cross-Sectional Survey. Hosp Pediatr. 2015 Jan;5(1):18-26. doi: 10.1542/hpeds.2014-0084.
Results Reference
background
PubMed Identifier
34400573
Citation
Gonzalez L. Pediatric Opioid Prescribing: A Call for Calm. Pediatrics. 2021 Sep;148(3):e2021052190. doi: 10.1542/peds.2021-052190. Epub 2021 Aug 16. No abstract available.
Results Reference
background
PubMed Identifier
30889145
Citation
Singla A, Qureshi R, Chen DQ, Nourbakhsh A, Hassanzadeh H, Shimer AL, Shen FH. Risk of Surgical Site Infection and Mortality Following Lumbar Fusion Surgery in Patients With Chronic Steroid Usage and Chronic Methicillin-Resistant Staphylococcus aureus Infection. Spine (Phila Pa 1976). 2019 Apr 1;44(7):E408-E413. doi: 10.1097/BRS.0000000000002864.
Results Reference
background
PubMed Identifier
28263228
Citation
Chan P, Skaggs DL, Sanders AE, Villamor GA, Choi PD, Tolo VT, Andras LM. Pain is the Greatest Preoperative Concern for Patients and Parents Before Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1245-E1250. doi: 10.1097/BRS.0000000000002147.
Results Reference
background
PubMed Identifier
24770995
Citation
Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014 May;8(3):257-63. doi: 10.1007/s11832-014-0587-y. Epub 2014 Apr 27.
Results Reference
result

Learn more about this trial

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

We'll reach out to this number within 24 hrs